Intervention Study With Crop Lettuce Enriched With Iodine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum Thyroid markers
研究概览
简要总结
The aim of the project is to study of the influence of Lettuce crop enriched with Iodine on Thyroid hormone synthesis. Secondary outcome to find out iodine presence in urine in order to evaluate vegetables, like little crop, as Iodine biocarrier
详细描述
Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.
The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •age: 18-65 years
- •healthy status
- •no drug therapy or integration therapy
排除标准
- •Inflammatory chronic disease
- •use of medication or suffering from any condition
- •pregnancy
- •breastfeeding
- •current smokers
研究组 & 干预措施
No Intervention: (control group)
The control group was assigned to crop lettuce without any biofortification but with the same characteristic of bioforticated lettuce (soil, water, harvesting time)
干预措施: Lettuce with not biofortification (Dietary Supplement)
Experimental: intervention group
The intervention group was assigned to biofortificated Iodine crop lettuce.
干预措施: Lettuce biofortificated with Iodine (Dietary Supplement)
结局指标
主要结局
Serum Thyroid markers
时间窗: 10 days
serum levels of free tri-iodothyronine (FT3 ng/L), free thyroxine (FT4 ng/L) and thyroid-stimulating hormone (TSH ng/L) will be assessed at baseline and after 10 days
Urine Iodine concentration
时间窗: 10 days
Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 1
时间窗: 10 days
glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 2
时间窗: 10 days
insulin (mUI/L) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 3
时间窗: 10 days
Potassium (mmol/L) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 4
时间窗: 10 days
Ferritin (mg/L), free Iron (mg/L), transferrin (mg/L), total proteins (mg/L), Magnesium (mg/L), Calcium (mg/L), Vitamin D (mg/L), HCRP (mg/L), Phosphate (mg/L), Cortisol (mg/L)will be assessed at baseline and after 10 days
Haematology and serum chemistry values 5
时间窗: 10 days
AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days
次要结局
- body composition (%)(10 days)
- Gastric Hormones(10 days)
- Oxidative stress markes(10 days)
- Bone metabolism(10 days)
- Inflammatory markers(10 days)
- Weigh(10 days)
- Hight(10 days)
- body mass index (BMI)(10 days)
研究者
Sonya Vasto
Associate professor
University of Palermo